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    Oren Livnat

    Managing Director and Senior Equity Research Analyst at H.C. Wainwright

    Oren Livnat is a Managing Director and Senior Equity Research Analyst at H.C. Wainwright, specializing in the healthcare sector with a focus on biotechnology and specialty pharmaceuticals. He actively covers companies such as Zevra Therapeutics, Grace Therapeutics, ANI Pharmaceuticals, Menlo Therapeutics, Pacira Pharmaceuticals, and VYNE Therapeutics, with a recent one-year success rate of 42.1% and an average annual return around 0.5% according to TipRanks, and a historical average stock price target met ratio of 41.08% with an average upside of 50.68%. Livnat has issued over 438 ratings on 25 stocks since making his first public recommendation, and his notable best-performing call was on VYNE Therapeutics, with a 38.12% return in just 16 days. His credentials include a career focus in life sciences research and compliance with investment industry regulations, supported by active registration and licenses with FINRA.

    Oren Livnat's questions to ZEVRA THERAPEUTICS (ZVRA) leadership

    Oren Livnat's questions to ZEVRA THERAPEUTICS (ZVRA) leadership • Q4 2024

    Question

    Oren Livnat asked for a characterization of the initial bolus of MIPLYFFA patient referrals, an update on reimbursement approval rates for the 109 enrollments, more color on payer conversations, and the expected average net revenue per patient.

    Answer

    CCO Joshua Schafer clarified that of the first 90 enrollments, 69 were from the EAP. He noted that reimbursement rates are improving, with most patients gaining access via direct formulary coverage or the medical exception process. He described payer conversations as focused on clinical benefits. CFO R. Clifton stated that while specific gross-to-net details would not be shared, he does not expect the company to be aggressive with discounting.

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    Oren Livnat's questions to ZEVRA THERAPEUTICS (ZVRA) leadership • Q3 2024

    Question

    Oren Livnat asked about Zevra's plans for providing 2025 sales guidance for MIPLYFFA, the level of market awareness outside the EAP, whether the current SG&A expense is a good run-rate, and the status of OLPRUVA's patient numbers and revenue outlook.

    Answer

    President and CEO Neil McFarlane confirmed there are no plans to provide sales guidance in the early launch phase. Chief Commercial Officer Joshua Schafer noted that awareness is high due to strong patient advocacy relationships and sales force overlap. CFO LaDuane Clifton clarified that Q3 SG&A reflects the full commercial infrastructure but was inflated by a one-time $2.5 million stock compensation charge. Regarding OLPRUVA, Joshua Schafer confirmed active patients remain on therapy but did not provide numbers, suggesting revenue will remain de minimis until their refined strategy gains traction.

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    Oren Livnat's questions to Xeris Biopharma Holdings (XERS) leadership

    Oren Livnat's questions to Xeris Biopharma Holdings (XERS) leadership • Q4 2024

    Question

    Oren Livnat sought clarification on Recorlev's growth outlook, asking if it referred to percentage growth rates or absolute patient additions. He also questioned potential changes in market access, the status of FDA discussions for XP-8121, the possibility of achieving cash flow breakeven in 2025, and expected Q1 seasonality for Recorlev.

    Answer

    CFO Steven Pieper clarified that Recorlev's growth should be viewed in terms of absolute patient additions, given the larger base. CEO John Shannon confirmed no changes in reimbursement and stated that FDA dialogue for XP-8121 is ongoing. Pieper declined to guide on cash flow, emphasizing the focus on P&L strength and positive adjusted EBITDA. Shannon acknowledged typical Q1 payer resets would cause a slight slowdown for Recorlev before a rebound.

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    Oren Livnat's questions to Xeris Biopharma Holdings (XERS) leadership • Q3 2024

    Question

    Oren Livnat asked for details on Recorlev's growth drivers, including dose and gross-to-net dynamics, and the patient mix between new and switch patients. He also questioned what it would take for the Gvoke market to accelerate and what level of detail to expect in 2025 guidance.

    Answer

    CEO John Shannon emphasized that Recorlev's growth is primarily driven by a rapid increase in new patient starts, not changes in dose or payer dynamics. For Gvoke, he stated that Xeris is driving all market growth and will continue to do so. He also confirmed that the company will provide more and different metrics in its 2025 guidance to better reflect the business's value creation.

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    Oren Livnat's questions to AVADEL PHARMACEUTICALS (AVDL) leadership

    Oren Livnat's questions to AVADEL PHARMACEUTICALS (AVDL) leadership • Q4 2024

    Question

    Oren Livnat of H.C. Wainwright inquired about the messaging for switching patients from Xywav, particularly regarding their tenure on the therapy, and asked about hurdles such as insurance coverage. He also sought an update on the expected timing for rulings on the pending injunction appeal and the royalty determination litigation.

    Answer

    Executive Gregory Divis stated that LUMRYZ has over 90% commercial coverage, comparable to competitors, and that perceived access issues are manageable objections. He noted that switch patients come from diverse backgrounds, not just one specific demographic. Executive Thomas McHugh provided litigation timelines, expecting a ruling on the injunction appeal within 2-3 months of the February 7th hearing and confirming the royalty determination ruling is still pending.

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    Oren Livnat's questions to AVADEL PHARMACEUTICALS (AVDL) leadership • Q3 2024

    Question

    Oren Livnat asked for details on the higher discontinuation rates among new-to-oxybate patients, the role of RYZUP support services, potential reimbursement hurdles like reauthorizations, expected formulary changes in 2025, and the current annualized net value per patient.

    Answer

    Executive Richard Kim attributed higher discontinuation rates in new patients to a lack of familiarity with oxybate therapy, emphasizing the need for RYZUP nurse navigators to manage expectations on dosing and tolerability. CEO Gregory Divis added that support is now more tailored by patient type. CFO Thomas McHugh confirmed the average annualized net revenue per patient is approximately $100,000, which includes patients receiving free drug.

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    Oren Livnat's questions to ANI PHARMACEUTICALS (ANIP) leadership

    Oren Livnat's questions to ANI PHARMACEUTICALS (ANIP) leadership • Q4 2024

    Question

    Oren Livnat from H.C. Wainwright asked for clarity on the ILUVIEN and YUTIQ transition, questioning if YUTIQ would be permanently discontinued and how potential timing, training, or cost differences might disrupt physicians. He also inquired about the importance of the Cortrophin prefilled syringe launch and its potential impact on net price.

    Answer

    Executive Nikhil Lalwani clarified the plan is to consolidate both indications under the ILUVIEN brand, which simplifies processes for physicians. He stated the transition is well-planned with inventory build-up and that the procedure and pricing are not materially different. Regarding the prefilled syringe, he positioned it as a convenience-enhancing option for patients that should help drive overall market growth, rather than impacting price.

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    Oren Livnat's questions to Pacira BioSciences (PCRX) leadership

    Oren Livnat's questions to Pacira BioSciences (PCRX) leadership • Q4 2024

    Question

    Oren Livnat asked about the assumptions behind the NOPAIN Act uptake, seeking to understand potential impediments to rapid adoption and any early evidence of successful reimbursement. He also questioned the company's capital allocation strategy, asking why Pacira isn't more aggressive with share buybacks given its confidence in EXPAREL's intellectual property. In a follow-up, he inquired about the drivers for the 2025 gross margin guidance.

    Answer

    CEO Frank Lee explained that NOPAIN uptake will take time as customers build awareness and test the new J-code, projecting a more meaningful ramp in the second half of the year. He noted encouraging early signs of reimbursement and commercial payer wins. Regarding capital allocation, Lee emphasized a disciplined, balanced approach to funding operations, advancing the pipeline like GQ Bio, managing debt, and utilizing the existing $125 million buyback authorization. CFO Shawn Cross and CEO Frank Lee addressed gross margins, noting potential quarter-to-quarter variability but expecting improvement over time with increased sales volume.

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    Oren Livnat's questions to Pacira BioSciences (PCRX) leadership • Q3 2024

    Question

    Oren Livnat asked about the expected timeline for customer implementation of the NOPAIN Act and Pacira's readiness, as well as the long-term outlook for the legislation following the recent election.

    Answer

    CEO Frank Lee stated that while Pacira is prepared, he expects it will take time for customers to implement the new reimbursement, anticipating a more significant impact in the second half of 2025 and beyond. He expressed confidence in the long-term viability of NOPAIN, citing the strong bipartisan support it received, and believes this support will continue due to the ongoing opioid crisis.

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    Oren Livnat's questions to Tarsus Pharmaceuticals (TARS) leadership

    Oren Livnat's questions to Tarsus Pharmaceuticals (TARS) leadership • Q4 2024

    Question

    Oren Livnat asked for clarification on the 'on-demand' use case for the TP-05 Lyme disease therapy. He also questioned a potential Q4 channel stocking for XDEMVY, the incremental nature of the Q1 DTC spend, and retreatment rates among early adopters.

    Answer

    An executive explained that TP-05 is considered 'on-demand' because it is rapidly absorbed and provides protection within hours, making it suitable for prophylactic use. Chief Financial Officer Jeff Farrow confirmed there was no significant Q4 channel stocking, with inventory stable at ~2.5 weeks. He clarified the Q1 DTC spend of $15M is incremental to the ~$8M spent in Q4. He also reiterated the overall mid-single-digit retreatment rate, noting the 20% long-term target is based on clinical trial data.

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    Oren Livnat's questions to Tarsus Pharmaceuticals (TARS) leadership • Q3 2024

    Question

    Oren Livnat of H.C. Wainwright & Co. asked for an explanation of the quarter-over-quarter decrease in SG&A expenses despite the sales force expansion and inquired about the company's early thoughts on potential pricing for XDEMVY in the European market.

    Answer

    CEO Bobak Azamian attributed the flat SG&A to the timing of the sales force onboarding (starting in September), offset by other general sales and marketing costs, and noted that SG&A is expected to increase in Q4. Chief Commercial Officer Aziz Mottiwala stated that while the European market has a significant need, work is ongoing to understand the country-specific reimbursement dynamics, emphasizing XDEMVY's unique value proposition.

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    Oren Livnat's questions to COLLEGIUM PHARMACEUTICAL (COLL) leadership

    Oren Livnat's questions to COLLEGIUM PHARMACEUTICAL (COLL) leadership • Q3 2024

    Question

    Oren Livnat of H.C. Wainwright & Co. asked about the appointment of Vikram Karnani as CEO, questioning the fit of his rare disease background with Collegium's mass-market portfolio. He also asked if Jornay PM's growth could accelerate post-transition, how it differentiates from other branded ADHD drugs, and a housekeeping question about product inventory levels during the quarter.

    Answer

    Executive Michael Heffernan defended the CEO choice, highlighting Vikram Karnani's transferable skills from leading Horizon Therapeutics' massive growth. Executive Scott Dreyer confirmed Jornay PM's growth (31.2% Y/Y) was strong through the transition and sees future acceleration from targeted investments and raising patient awareness. He noted physicians view Jornay's evening dosing as uniquely differentiated. Executive Colleen Tupper added that product inventory was stable, with only Jornay PM slightly lower than normal due to legacy ordering patterns.

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    Oren Livnat's questions to Verrica Pharmaceuticals (VRCA) leadership

    Oren Livnat's questions to Verrica Pharmaceuticals (VRCA) leadership • Q2 2024

    Question

    Asked about VP-315's potential systemic (abscopal) effects, the company's strategic plans for the asset (partnership vs. internal development), the purpose of analyzing tissue samples, and the mechanics of the YCANTH forward deployed inventory model.

    Answer

    The company is not yet ready to comment on data regarding a potential abscopal effect for VP-315. They are keeping all strategic options open for the asset, including partnerships. The analysis of tissue and blood samples is to better characterize the drug's mechanism of action. The YCANTH inventory model is described as an agile, blended approach offering both consignment and direct purchase options to meet customer needs.

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    Oren Livnat's questions to CARA leadership

    Oren Livnat's questions to CARA leadership • Q3 2023

    Question

    Asked for expectations on what constitutes a clinically meaningful improvement in pruritus for the KIND 1 study population and whether the key hurdle for the drug is commercial or regulatory.

    Answer

    The company stated the study population is unique and historical data doesn't apply; they have internal, KOL-vetted thresholds for a go/no-go decision. The regulatory hurdle for the pivotal program is a statistically significant 4-point response. Commercially, the drug is well-positioned as the first oral agent for a large, underserved market.

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    Oren Livnat's questions to SCYNEXIS (SCYX) leadership

    Oren Livnat's questions to SCYNEXIS (SCYX) leadership • Q2 2022

    Question

    Oren Livnat asked about the commercial dynamics of BREXAFEMME, including typical patient copays, financial assistance programs, prior authorization hurdles, the investment level for the 'Say No More' DTC campaign, and any feedback from KOLs regarding the approval of Mycovia's competing product.

    Answer

    Chief Commercial Officer Christine Coyne reported that while patient copays vary, the majority fall within the $30-$50 range, supported by an ongoing copay card program. She noted that the upcoming RVVC indication is helping facilitate positive payer discussions. Coyne confirmed the expansion of DTC initiatives, with SG&A being reallocated based on ROI. President and CEO Dr. Marco Taglietti added that overall SG&A is planned to remain flat and described the approval of the competitor Mycovia as a 'silver lining,' as its highly restrictive label helps highlight BREXAFEMME's broader utility.

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    Oren Livnat's questions to SCYNEXIS (SCYX) leadership • Q1 2022

    Question

    Oren Livnat of H.C. Wainwright & Co. questioned if the new 'empowerment' messaging and focus on 'high prescribers' for BREXAFEMME indicated a change in commercial strategy. He also sought clarity on the regulatory pathway for the FURI and CARES programs, specifically regarding the use of the LPAD pathway and FDA discussions for a potential 2024 approval.

    Answer

    Chief Commercial Officer Christine Coyne clarified that the messaging is a refinement based on customer feedback, not a strategy shift, and the focus remains on high-prescribing physicians. Chief Medical Officer Dr. David Angulo detailed the regulatory plan to align data from the MARIO, FURI, and CARES studies to support a broad label for invasive candidiasis. He confirmed a conceptual agreement exists with the FDA on combining these data packages for a potential approval.

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    Oren Livnat's questions to SCYNEXIS (SCYX) leadership • Q4 2021

    Question

    Oren Livnat of H.C. Wainwright asked for more detail on prescriber behavior, including whether some practices are writing significantly more scripts and what factors are driving this. He also inquired about the types of patients receiving BREXAFEMME in the early launch phase and the status of the planned direct-to-patient marketing campaign. Later, he asked if more detailed efficacy data from the CANDLE study would be released to better differentiate it from fluconazole.

    Answer

    Chief Commercial Officer Christine Coyne confirmed that some physicians are high-volume prescribers, driven by early engagement and positive outcomes, and that a direct-to-patient campaign is planned for summer 2022. CEO Dr. Marco Taglietti suggested initial patients are likely those unsatisfied with previous azole treatments. Regarding the CANDLE study, Dr. Taglietti stated that more detailed data, including additional efficacy metrics, would be disclosed at medical meetings in the summer.

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    Oren Livnat's questions to VYNE Therapeutics (VYNE) leadership

    Oren Livnat's questions to VYNE Therapeutics (VYNE) leadership • Q2 2021

    Question

    Oren Livnat of H.C. Wainwright & Co. asked whether the decision to exit the commercial business reflects a broader challenge for small companies or is specific to the topical acne market. He also sought technical details on the proof of concept for the topical BETi platform and clarification on the clinical trial requirements for a generic version of AMZEEQ.

    Answer

    President & CEO Dave Domzalski reiterated that launching products is challenging for a small company, especially during a pandemic, and that a partner with more resources could better maximize the franchise's potential. Chief Scientific Officer Iain Stuart detailed that the topical VYN201 is uniquely designed with a metabolic liability to reduce systemic exposure. General Counsel Mutya Harsch confirmed there is no product-specific FDA guidance for topical minocycline yet, but similar complex generics have been required to conduct clinical trials.

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    Oren Livnat's questions to VYNE Therapeutics (VYNE) leadership • Q1 2021

    Question

    Oren Livnat from H.C. Wainwright asked about the process for optimizing patient access programs, the effectiveness of using prior authorizations to influence payers, and the materiality of the AMZEEQ label change regarding antibiotic resistance. He later followed up on rosacea market seasonality, patient visit trends, and whether the company would begin breaking out revenue for AMZEEQ and ZILXI.

    Answer

    Chief Commercial Officer Matt Wiley explained that the company is carefully balancing out-of-pocket costs and abandonment rates for its access programs and has seen good success with prior authorizations via its specialty pharmacy network. Both Wiley and CEO Dave Domzalski highlighted that the new label data on low antibiotic resistance is a compelling point for discussions with physicians and payers. Regarding the follow-up, management noted an increase in rosacea patient throughput, and CFO Andrew Saik confirmed the company intends to break out product revenues later in the year or in the next fiscal year, but not in the immediate future.

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